Treatment of Chronic Cluster Headache with TENS and ONS

Summary

The study is an investigator-initiated, prospective, randomized, placebo-controlled, double blind clinical trial that aims to investigate the effect of transcutaneous electrical nerve stimulation (TENS) and occipital nerve stimulation (ONS) on attack frequency and severity in patients with chronic cluster headache (CH).

Study outline

Month 1: Baseline. Establishment of a baseline profile of the participants CH attacks (severity, duration, medicine utilization etc), health-related quality of life (QoL) and symptoms of anxiety and depression. No active treatment. Follow-up visit after 30 days.

Months 2-4: TENS period. All participants will receive TENS-treatment. Clinical follow-up visit by the end of month four.

Months 5-7: Double-blinded, randomized experimental period. All participants will have an ONS-system (lead, impulse generator) implanted and will be randomized 1:1 to receive either 1) burst (paresthesia-free) ONS or 2) placebo (deactivated ONS system). Clinical follow-up visit by the end of month seven.

Months 8-10: Open label period. All participants will receive tonic (conventional, paresthesia-inducing) ONS.

Clinical follow-up visit by the end of month ten.

During every study phase each participant will fill out a weekly electronic headache registration as well as answering questionnaires regarding health-related quality of life and symptoms of anxiety and depression before every follow-up visit.

Conditions

• Chronic Cluster Headache
• Primary Headache Disorder
• Headache
• Cluster Headache
• Pain
• Cephalgia
• Trigeminal Autonomic Cephalgia

Interventions

DEVICE

Paresthesia-free (burst) ONS

Stimulation intensity target of 60% of paresthesia threshold.

DEVICE

Placebo

ONS system deactivated

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Danish Headache Center

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Ida S Fogh-Andersen, MD PhD fellow · University of Aarhus

• Kaare Meier, MD PhD · University of Aarhus

• Jens Christian H Sørensen, MD PhD DMSc · University of Aarhus

• Rigmor H Jensen, MD PhD DMSc · Danish Headache Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-27

Primary Completion

2024-07-15

Completion

2024-07-31

FDA Device

Yes

Countries

• Denmark

Study Locations